BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1918070 · Received December 9, 2010

    Report

    Report Number
    3005075853-2010-06968
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT PT EXPERIENCED A FEELING OF WEAKNESS. CT SCAN CONFIRMED ENLARGED VENTRICLES. SURGEON CHANGED THE PRESSURE WITH NO IMPROVEMENT. A SHUNTOGRAPHY THEN CONFIRMED FLUID WAS NOT FLOWING THROUGH THE DEVICE. AS A RESULT THE VALVE WAS REVISED.

    Description of Event or Problem · 1

    TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED AFTER 36 MINUTES OF ONYX INJECTION, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN CONTINUED TO INJECT ONYX BUT WITHOUT SUCCESS AFTER 3-4 ATTEMPTS. THE PHYSICIAN THEN MOVED THE RX TUBE AND NOTICED ONYX WAS IN THE PERICALLOSAL ARTERY. THE CATHETER WAS WITHDRAWN FROM THE PT AND A HOLE WAS NOTED AT 10 CM FROM THE DISTAL TIP. NO PT INJURY REPORTED. SAME EVENT AS MDR # 2029214-2011-00008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE STAPLED BUT WOULD NOT CUT. THE SURGEON USED A BISTOURY TO DO THE SECTION OF THE TISSUES. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4TJ21

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE